Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03209700
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2017-07-03
Brief Title:
Re-treatment From a Phase I Study of MSC-AFP in Patients With Perianal Fistulas
Sponsor:
William A Faubion MD
Organization:
Mayo Clinic
Study Overview
Official Title:
Re-treatment for Partial or Non-responders for a Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Perianal Fistulas
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MSC-AFP
Brief Summary:
This study is an extension to re-treat partial and non-responders from the previously approved Phase 1 MCS-AFP protocols IRB 12-009716 Crohns Disease perianal fistulas and 15-003200 cryptoglandular perianal fistulas
Detailed Description:
This study is an extension to re-treat partial and non-responders from the previously approved Phase 1 MCS-AFP protocols IRB 12-009716 Crohns Disease perianal fistulas and 15-003200 cryptoglandular perianal fistulas This study will enroll patients that have persistent symptomatic perianal disease despite being treated with an MSC coated fistula plug and also treat patients that have had recurrence of their perianal fistula
As per the previously approval treatment under IND 15356 patients will have a single affected fistula treated which is the same fistula that was treated in the original protocol The matrix for delivering the cells is a Gore Bio-A Fistula Plug
Subjects will be screened at outpatient clinic visits and interested qualified subjects will be offered participation in the trial and consented At the first study visit Visit 1 Screening visit the patient will be evaluated and assessment will be made if an EUA is clinically necessary to assess the fistula As this is a re-treatment trial patients with incomplete response to initial plug placement typically have close follow up recent MRI imaging and may have a seton in place If an EUA is clinically indicated this would be by a colorectal surgeon for drainage of sepsis and placement of a seton as part of the standard clinical care for perianal fistula
Patients will return on Day 1 Week 4 Week 12 and Week 24
As per the previously approval treatment under IND 15356 patients will have a single affected fistula treated which is the same fistula that was treated in the original protocol The matrix for delivering the cells is a Gore Bio-A Fistula Plug
Subjects will be screened at outpatient clinic visits and interested qualified subjects will be offered participation in the trial and consented At the first study visit Visit 1 Screening visit the patient will be evaluated and assessment will be made if an EUA is clinically necessary to assess the fistula As this is a re-treatment trial patients with incomplete response to initial plug placement typically have close follow up recent MRI imaging and may have a seton in place If an EUA is clinically indicated this would be by a colorectal surgeon for drainage of sepsis and placement of a seton as part of the standard clinical care for perianal fistula
Patients will return on Day 1 Week 4 Week 12 and Week 24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None